The earliest research and development of clobetasol propionate was in the 1960s. It is a topical corticosteroid drug with chiral carbon in its structure. The right-handed isoform is highly active, but the racemic isoform is often used.
This ingredient was launched in Europe in 1978 and in the United States in 1985. It was considered one of the most potent corticosteroids at the time.
Its advantages are rapid action and strong efficacy, but it is not suitable for long-term use.
White or almost white crystalline powder, insoluble in water. It is mainly metabolized to carboxylic acids and ketones in the liver, with no active metabolites.
Why choose Prius Bio?
1. More than 10 years of production experience in API products, and has obtained export rights.
2. Since its establishment, the factory has exported products to Europe, North America, South America and Southeast Asia. Our company's products are sold to many countries and thousands of companies around the world, and have been recognized by customers.
3. Advanced testing equipment. Including drug stability test chambers, gas chromatographs, liquid chromatographs, etc.
4. Quality testing of APIs and pharmaceutical intermediates.
| Items | Requirements | Results | |
| Ref Standard | USP38 | ||
| Assay(HPLC,basis on drying) | 97.0%~102.0% | 99.8% | |
| Appearance | White or almost white crystalline powder | Complies | |
| Solubility | Practically insoluble in water,slightly soluble in benzene and diethyl ether,sparingly soluble ethanol,soluble in acetone and in dimethyl sulfoxide,in chloroform,in methanol and in dioxane | Complies | |
| Identification(IR) | Commplies with the standard | Complies | |
| Specific Rotation | +98°~+104° | +101.6° | |
| Melting Point | about 196℃ | 194.0℃~196.0℃ | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Loss on Drying | ≤2.0% | 0.31% | |
| Heavy Metals | ≤20ppm | Complies | |
| Related Substances(HPLC) | single impurity | N.m.t 1.0% | 0.18% |
| sum impurity | N.m.t 2.0% | 0.31% | |
| Organic Volatile Impurities | |||
| THF | ≤720ppm | Complies | |
| Methanol | ≤3000ppm | Complies | |
| DMF | ≤880ppm | Complies | |
| Pyridine | ≤200ppm | Complies | |
| Dichloromethane | ≤600ppm | Complies | |
| Ethanol | ≤5000ppm | Complies | |
| Acetone | ≤5000ppm | Complies | |
| Packaging and Storage | Preserve in tight,light-resistant containers. | ||
| Conclusion | The product conforms to the requirements of USP38. | ||
1. Its efficacy has been confirmed in many clinical trials and can be used to treat skin diseases such as chronic eczema, neurodermatitis, and psoriasis. Its anti-inflammatory effect is 600 times that of hydroxycortisone and 50 times that of fluticasone.
2. Clobetasol propionate has anti-allergic, anti-proliferative, and immunosuppressive effects. This product has a strong capillary contraction effect.
1. It is available in Clobetasol propionate cream, ointment, lotion, gel and other dosage forms. The common specifications of cream and ointment are 0.02% and 0.05%.
It can be absorbed through the skin after external application. After absorption, it is mainly metabolized in the liver and excreted through the kidneys.
2. The FDA has approved clobetasol propionate ophthalmic nanosuspension, 0.05% eye drops, for the relief of inflammation and pain after ophthalmic surgery.
Compared with traditional ophthalmic drugs, the new formula of this eye drop provides patients with a more convenient and simple dosing regimen, greatly improving the patient's treatment experience.
Reference
[1]. E. Fougera and Co. "Clobetasol Propionate Cream Usp, 0.05% Clobetasol Propionate Ointment USP, 0.05%". Daily Med. U.S. National Library of Medicine. Archived from the original on 23 May 2009. Retrieved 3 July 2009.
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